Linking Brain to Behaviour Research in SCI

NCT ID: NCT01963026

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-07-31

Brief Summary

Introduction In recent years, client-centred and task-oriented training have emerged as important methods in rehabilitation including the rehabilitation of persons with spinal cord injury (SCI). The task-oriented intervention focuses on resolving, reducing and preventing impairment, developing effective task-specific strategies and adapting functional goal-oriented strategies to changing environmental conditions. Currently, task-specific training is mainly achieved by constant practice (i.e. repeating the task without variation) and is reported to improve performance of the trained task, but to have a negative impact on untrained tasks. Practice variability, however, is reported being advantageous to transfer training results into daily live. This paradox poses challenges in clinical practice, where task-specific training is essential to deliver client-centred training in order to focus on the patients' specific individual goals, but practice variability is important to be able to transfer the learned task into daily practice. Questions regarding the effective elements within rehabilitative interventions and the exact mechanisms behind the cerebral changes they may induce, remain. These questions require further research, for which ultra-high field fMRI techniques will be used. Furthermore, compensation of muscle function loss (i.e. the development of new muscle synergies) plays an important role in the improvement of skill performance in cervical SCI. Surface EMG allows to study the changes in muscle coordination, parallel to the changes at cerebral level.

Aims This study aims to

1. investigate which basic neural mechanisms of motor learning underlie functional recovery of arm hand skilled performance during client-centred task-oriented training of the upper limb in patients with cervical spinal cord injury and

2. investigate the contribution of 'practice variability' in contrast to 'constant practice' on arm-hand skilled performance, motor control and neural changes.

Study design This study features a multiple single-case experimental design (A-B-C design) with baseline (phase A) (6 weeks), intervention B (phase B) (3 weeks) and intervention C (phase C) (3 weeks). Intervention B will contain the 'practice variability' component. Intervention C will feature the 'constant practice' component. The order of phase B and C will be randomly assigned to participants. Four measurements during baseline and after each intervention phase (B and C) will be performed, thus producing a time series, per measure, for each patient. Also, meta-analyses on the pooled single-case data will be performed.

Setting/population Six patients with a cervical SCI (complete and incomplete) will be recruited from the Spinal cord unit of Adelante Rehabilitation Centre in the (sub)acute phase.

Intervention After therapy as usual (intervention A), the Task-oriented Client-centred Upper Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be provided. In this program individual goals will be extracted using the Canadian Occupational Performance Measure(COPM) and the training program is based on a task-analysis and uses principles of training physiology and motor learning. Intervention B will consist of the ToCUEST program, including the component 'practice variability' (ToCUEST variability). Intervention C will consist of a modified ToCUEST program in which the component 'practice variability' will be replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of these components. Intervention A' will be therapy as usual.

Measurements Measurements will be taken at the level of activities (arm hand skilled performance, i.e. Van Lieshout Test, Spinal Cord Independence Measure, Goal Attainment Scale) and body function (Upper Extremity Motor Score, Graded Redefined Assessment of Strength Sensibility and Prehension Test, Surface EMG), and at cerebral level, i.e. neural activity changes (by means of ultra-high field fMRI).

The fMRI measurements will be taken before and after each intervention B and C in 4 patients (2 with complete and 2 with incomplete lesion).

Data-analyses Baseline data stability and any baseline trends regarding the outcome measures at body function level and activity level will be assessed. To control for, e.g., spontaneous recovery effects, baseline data (phase A) will be used in a computer-based detrending model. For the meta-analyses, mean data per outcome measure, per phase, per subject will be pooled and subsequently analysed using non-parametric statistics, i.e. Friedman analyses and Wilcoxon tests.

Conditions

Cervical Spinal Cord Injury

Keywords

spinal cord injury; upper extremity; skill performance; motor learning

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ToCUEST (constant or variable practice)

After therapy as usual (intervention A), the Task-oriented Client-centred Upper Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be given. In this program individual goals will be extracted using the COPM (Canadian Occupational Performance Measure) and the training program is based on a task-analysis and uses principles of training physiology and motor learning. Intervention B will consist of the ToCUEST program, including the component 'practice variability' (ToCUEST variability). Intervention C will consist of a modified ToCUEST program in which the component 'practice variability' will be replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of these components. Intervention A' will be therapy as usual.

Group Type: EXPERIMENTAL

ToCUEST featuring a 'variable practice' approach.

Intervention Type: OTHER

Intervention Variable practice: The ToCUEST (Task-Oriented Client-centred Upper Extremity Skill Training) module \[17\] will be given to the participants, in which individual goals will be extracted using the COPM (Canadian Occupational Performance Measure). The training program will start with a task analysis and is based on principles of training physiology and motor learning, including variability practice, random practice, distribution based practice, feedback, whole learning. A detailed description of the ToCUEST module is given in Spooren et al. \[17\]. Intervention B will be called 'ToCUEST variability' in the present project.

ToCUEST featuring a 'constant practice' approach.

Intervention Type: OTHER

Intervention Constant practice: In order to evaluate the contribution of the component 'variability practice' in contrast with 'constant practice' the participants will be offered the modified ToCUEST ('ToCUEST constant') module in which the component 'variability practice' is replaced by 'constant practice'.

Interventions

ToCUEST featuring a 'variable practice' approach.

Intervention Variable practice: The ToCUEST (Task-Oriented Client-centred Upper Extremity Skill Training) module \[17\] will be given to the participants, in which individual goals will be extracted using the COPM (Canadian Occupational Performance Measure). The training program will start with a task analysis and is based on principles of training physiology and motor learning, including variability practice, random practice, distribution based practice, feedback, whole learning. A detailed description of the ToCUEST module is given in Spooren et al. \[17\]. Intervention B will be called 'ToCUEST variability' in the present project.

Intervention Type: OTHER

ToCUEST featuring a 'constant practice' approach.

Intervention Constant practice: In order to evaluate the contribution of the component 'variability practice' in contrast with 'constant practice' the participants will be offered the modified ToCUEST ('ToCUEST constant') module in which the component 'variability practice' is replaced by 'constant practice'.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• in)complete C-SCI at level C3-T1; age between 18 and 70 years; patients are able to sit in a wheelchair for at least for 2 consecutive hours; presence of problems with specific arm-hand skilled performance

Exclusion Criteria

• opinion of an independent rehabilitation physician that additional neurological, orthopaedic or rheumatologic diseases strongly interfere with Activities of Daily Living (ADL) functioning and arm hand skilled performance; inability to perform arm hand skilled performance measurements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adelante rehabilitation Centre

UNKNOWN

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: collaborator

Adelante, Centre of Expertise in Rehabilitation and Audiology

OTHER

Sponsor Role: lead

Responsible Party

Dr. H.A.M. Seelen

Research Co-ordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henk AM Seelen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Adelante Centre of Expertise in Rehabilitation and Audiology (NL)

Annemie IF Spooren, Dr.

Role: PRINCIPAL_INVESTIGATOR

University College PXL (Belgium)

Amanda Kaas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University (NL)

Locations

Adelante Rehabilitation Centre

Hoensbroek, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL44697.068.13

Identifier Type: -

Identifier Source: org_study_id